Last updated: 11/03/2018 23:03:11
Skin Acceptability Assessment of 874A in subjects with sensitive skin Under Normal Usage Conditions
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Skin Acceptability Assessment of 874A in subjects with sensitive skin Under Normal Usage Conditions
Trial description: Evaluation for supportive safety purposes of a cosmetic product, aiming to obtain registration.
Primary purpose:
Not applicable
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Erythma emergence
Timeframe: Upto 25 days
Edema formation
Timeframe: Upto 25 days
Skin Peeling
Timeframe: Upto 25 days
Intensity of reaction
Timeframe: Upto 25 days
Sensations reported by study participants
Timeframe: Upto 25 days
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
35
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Skin Care
Product
Not applicable
Collaborators
Not applicable
Study date(s)
January 2016 to February 2016
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female
Age
18Years - 60Years
Accepts healthy volunteers
Yes
- Written Informed Consent obtained (ICF).
- Age group: 18 to 60 years old
- Pregnant or Breastfeeding women
- Skin marks in the test area which may interfere with the evaluation of potential skin reactions
Inclusion and exclusion criteria
Inclusion criteria:
- Written Informed Consent obtained (ICF). -Age group: 18 to 60 years old
- Gender: female
- Skin phototype (Fitzpatrick): I to IV
- Have sensitive skin (Verified by Sting test, grade ≥ 2)
- Willingness to comply with the trial procedures and requirements and attend the institute on the day(s) and time(s) scheduled for evaluations
Exclusion criteria:
- Pregnant or Breastfeeding women
- Skin marks in the test area which may interfere with the evaluation of potential skin reactions
- Active skin diseases (local or disseminated) that may interfere with study results
- Past history of allergic reactions, irritation or intense feelings of discomfort to topically used products: cosmetics or drugs; -Participants with immunodeficiency
- Intense sunlight exposure or tanning session within 15 days before the baseline evaluation or during the study
- Aesthetic or facial dermatological treatment within 3 weeks before the screening or during the study
- Therapeutic, topical or systemic use of the following drugs: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs and corticosteroids within 2 weeks before screening or during the study; in case of systemic use of corticosteroids within 30 days before study or during the study. -Oral or topical treatment with vitamin A acid and/or its derivatives within 1 month before initiation of study or during the study
- Vaccination within 3 weeks before or during the study -To be participating or have participated in another clinical trial completed within7 days before screening (if the previous clinical trial is any kind of compatibility test, the interval must be of 21 days or more, as defined in the Guidance for the Safety Evaluation of Cosmetic Products
- ANVISA – 2012) -Prisoners or patients involuntarily imprisoned
- Research participants from indigenous tribes;- Any condition not previously mentioned that in the investigator’s opinion may impair the study evaluation
- History of non-compliance or unwillingness to comply with the study protocol -Professionals directly involved in the conduct of this protocol and their families
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2016-03-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website